FibromyalgiaPhase 2/3NCT00000422
Tailored Treatments of Fibromyalgia
A Phase 2/3 study testing Cognitive-behavioral psychotherapy and physical exercise in people with Fibromyalgia, run by University of Washington at 1 site in United States.
Trial summary
This study will evaluate the effects of matching treatments to people with fibromyalgia syndrome (FMS) on the basis of their psychosocial and behavioral characteristics. We will look at how patients respond to a rehabilitation program that includes physical therapy and information about fibromyalgia. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Cognitive-behavioral psychotherapy and physical exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to May 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Able to visit Seattle based clinic 9 times
- Meet ACR criteria for FMS
Who cannot join
- Pregnancy
- Exercise contraindicated by physician due to other medical conditions
- Significant psychopathology
- Do not meet FMS criteria
- Cardiac problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subgroups of FMS: Symptoms, Beliefs and Tailored Treatments
This study will evaluate the effects of matching treatments to people with fibromyalgia syndrome (FMS) on the basis of their psychosocial and behavioral characteristics. We will look at how patients respond to a rehabilitation program that includes physical therapy and information about fibromyalgia. We will combine this program with psychological treatments that are either matched or mismatched to the way patients cope with and adapt to symptoms of FMS. The second aim of our study is to better understand how different FMS symptoms may vary together and how these symptoms change as a result of treatment in a person's natural environment. People with FMS and healthy people of the same ages will record their moods, thoughts, symptoms, activities, and fatigue levels three times a day for 2 weeks. Participants will use palm-top computers to record these "real-time" assessments. This approach will permit people to rate how they feel at a particular time rather than looking back in time.
Read the detailed description
Fibromyalgia syndrome (FMS) is a prevalent, chronic musculoskeletal pain disorder. Despite extensive study, researchers do not understand well the etiology and pathophysiologic mechanisms of FMS, and have not shown any treatment to be universally effective. We propose that FMS is a complex disorder involving multiple factors, both physical and psychosocial-behavioral.
In our previous research, we demonstrated that FMS patients are heterogeneous in the psychosocial-behavioral axis and can be classified into three distinct subgroups on the basis of their psychosocial adaptation to symptoms. In this study we will extend our previous research and attempt to match treatments to patients' psychosocial-behavioral characteristics. Specifically, we will test the efficacy of uniquely tailored treatment for each psychosocial subgroup.
We will treat three groups of FMS patients with one of three treatment protocols involving standard physical therapy and varying psychological treatments. A total of 312 FMS patients will undergo six half-day interdisciplinary treatment sessions consisting of psychological treatments and physical therapy emphasizing aerobic conditioning, pacing, and body mechanics. All protocols include a standardized physical therapy and either cognitive-behavioral pain management therapy, interpersonal skill training, or supportive counseling.
In addition to the treatment outcome study, we will prospectively assess various symptoms of FMS in the patients' natural habitats to better understand covariations of FMS symptoms. Patients will do repeated daily monitoring using a palm-top computer (ecological momentary assessment), which will permit us to evaluate process ratings compared to retrospective reports.
Overall, the results of these studies should establish the benefit of matching treatments to patient characteristics and enhance our understanding of the roles of cognitive-affective-behavioral adaptation by people with FMS.
- Conditions
- Fibromyalgia
- Being tested
- Cognitive-behavioral psychotherapy and physical exercise
- Keywords
- Fibromyalgia Syndrome (FMS), Physical therapy, Psychotherapy, Group counseling, Human therapy relations, Interpersonal relations, Chronic pain, Cognition, Emotion, Memory, Musculoskeletal disorder, Psychological stressor, Psychological adaptation, Outcomes research
- Medical subject headings
- Fibromyalgia, Chronic Pain, Musculoskeletal Diseases, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral psychotherapy and physical exerciseBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study startJul 1998
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 312 participants
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis Turk, University of Washington
- Investigators
- Dennis C. Turk, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000422
- Sponsor's protocol ID
- 14866-D
- Other IDs
- R01AR044724, NIAMS-036
- Status last verified
- Oct 2013
- First submitted
- 3 Nov 1999
- Last updated
- 30 Oct 2013
- Results posted
- No
Publications
Burwinkle T, Robinson JP, Turk DC. Fear of movement: factor structure of the tampa scale of kinesiophobia in patients with fibromyalgia syndrome. J Pain. 2005 Jun;6(6):384-91. doi: 10.1016/j.jpain.2005.01.355.
PubMed 15943960Robinson JP, Turk DC. Relations between self-reports and physical performance among fibromyalgia syndrome patients. J Pain 4, Number 2 (Suppl 1): 15, 2002.
Turk DC, Robinson JP. Predictors of self-reported activity level and activity limitations in fibromyalgia syndrome. J Pain 4, Number 2 (Suppl 1): 16, 2003.
Turk DC, Robinson JP, Burwinkle T. Prevalence of fear of pain and activity in patients with fibromyalgia syndrome. J Pain. 2004 Nov;5(9):483-90. doi: 10.1016/j.jpain.2004.08.002.
PubMed 15556826Burwinkle T, Robinson JP, Turk DC. The role of physical, demographic, and psychological factors in symptom reporting and treatments of fibromyalgia syndrome patients. J Pain 6 (Suppl 1), S79, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subgroups of FMS: Symptoms, Beliefs and Tailored Treatments
- ClinicalTrials.gov ID
- NCT00000422
- Acronym / sponsor ID
- 14866-D
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia Syndrome (FMS), Physical therapy, Psychotherapy, Group counseling, Human therapy relations, Interpersonal relations, Chronic pain, Cognition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jul 1998
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effects of matching treatments to people with fibromyalgia syndrome (FMS) on the basis of their psychosocial and behavioral characteristics. We will look at how patients respond to a rehabilitation program that includes physical therapy and information about fibromyalgia. We will combine this program with psychological treatments that are either matched or mismatched to the way patients cope with and adapt to symptoms of FMS. The second aim of our study is to better understand how different FMS symptoms may vary together and how these symptoms change as a result of treatment in a person's natural environment. People with FMS and healthy people of the same ages will record their moods, thoughts, symptoms, activities, and fatigue levels three times a day for 2 weeks. Participants will use palm-top computers to record these "real-time" assessments. This approach will permit people to rate how they feel at a particular time rather than looking back in time.
Detailed description
Fibromyalgia syndrome (FMS) is a prevalent, chronic musculoskeletal pain disorder. Despite extensive study, researchers do not understand well the etiology and pathophysiologic mechanisms of FMS, and have not shown any treatment to be universally effective. We propose that FMS is a complex disorder involving multiple factors, both physical and psychosocial-behavioral.
In our previous research, we demonstrated that FMS patients are heterogeneous in the psychosocial-behavioral axis and can be classified into three distinct subgroups on the basis of their psychosocial adaptation to symptoms. In this study we will extend our previous research and attempt to match treatments to patients' psychosocial-behavioral characteristics. Specifically, we will test the efficacy of uniquely tailored treatment for each psychosocial subgroup.
We will treat three groups of FMS patients with one of three treatment protocols involving standard physical therapy and varying psychological treatments. A total of 312 FMS patients will undergo six half-day interdisciplinary treatment sessions consisting of psychological treatments and physical therapy emphasizing aerobic conditioning, pacing, and body mechanics. All protocols include a standardized physical therapy and either cognitive-behavioral pain management therapy, interpersonal skill training, or supportive counseling.
In addition to the treatment outcome study, we will prospectively assess various symptoms of FMS in the patients' natural habitats to better understand covariations of FMS symptoms. Patients will do repeated daily monitoring using a palm-top computer (ecological momentary assessment), which will permit us to evaluate process ratings compared to retrospective reports.
Overall, the results of these studies should establish the benefit of matching treatments to patient characteristics and enhance our understanding of the roles of cognitive-affective-behavioral adaptation by people with FMS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Able to visit Seattle based clinic 9 times
- Meet ACR criteria for FMS
Key exclusion criteria (5 listed)
- Pregnancy
- Exercise contraindicated by physician due to other medical conditions
- Significant psychopathology
- Do not meet FMS criteria
- Cardiac problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-behavioral psychotherapy and physical exercise | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Results publication: PubMed 15943960Burwinkle T, Robinson JP, Turk DC. Fear of movement: factor structure of the tampa scale of kinesiophobia in patients with fibromyalgia syndrome. J Pain. 2005 Jun;6(6):384-91. doi: 10.1016/j.jpain.2005.01.355.
- Results publicationRobinson JP, Turk DC. Relations between self-reports and physical performance among fibromyalgia syndrome patients. J Pain 4, Number 2 (Suppl 1): 15, 2002.
- Results publicationTurk DC, Robinson JP. Predictors of self-reported activity level and activity limitations in fibromyalgia syndrome. J Pain 4, Number 2 (Suppl 1): 16, 2003.
- Results publication: PubMed 15556826Turk DC, Robinson JP, Burwinkle T. Prevalence of fear of pain and activity in patients with fibromyalgia syndrome. J Pain. 2004 Nov;5(9):483-90. doi: 10.1016/j.jpain.2004.08.002.
- Results publicationBurwinkle T, Robinson JP, Turk DC. The role of physical, demographic, and psychological factors in symptom reporting and treatments of fibromyalgia syndrome patients. J Pain 6 (Suppl 1), S79, 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis C. Turk, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cognitive-behavioral psychotherapy and physical exercise in people with Fibromyalgia, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000422, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.